FDA — authorised 15 February 1963
- Application: NDA012787
- Marketing authorisation holder: EUROFARMA
- Local brand name: SYNALAR
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Fluocinolone Acetonide in United States
FDA authorised Fluocinolone Acetonide on 15 February 1963
Marketing authorisations
FDA — authorised 11 June 1963
- Application: ANDA060700
- Marketing authorisation holder: EUROFARMA
- Local brand name: NEO-SYNALAR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 May 1964
- Application: NDA015296
- Marketing authorisation holder: EUROFARMA
- Local brand name: SYNALAR
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 25 July 1967
- Application: NDA016161
- Marketing authorisation holder: EUROFARMA
- Local brand name: SYNALAR-HP
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 16 June 1982
- Application: ANDA087159
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 16 December 1982
- Application: ANDA088045
- Marketing authorisation holder: INVATECH
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 3 February 1988
- Application: NDA019452
- Marketing authorisation holder: HILL DERMAC
- Local brand name: DERMOTIC
- Indication: OIL/DROPS — OTIC
- Status: approved
FDA — authorised 27 August 1990
- Application: NDA020001
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: CAPEX
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 20 December 1993
- Application: ANDA040059
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 September 1994
- Application: ANDA040041
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 31 October 1994
- Application: ANDA040042
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 October 1994
- Application: ANDA040035
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 October 2011
- Application: ANDA201759
- Marketing authorisation holder: AMNEAL
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 17 October 2011
- Application: ANDA201764
- Marketing authorisation holder: AMNEAL
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 9 August 2013
- Application: ANDA202848
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 9 August 2013
- Application: ANDA202847
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 25 June 2015
- Application: ANDA091514
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 2 September 2015
- Application: ANDA206422
- Marketing authorisation holder: LUPIN
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 25 April 2016
- Application: ANDA203377
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 25 April 2016
- Application: ANDA203378
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 19 May 2016
- Application: ANDA209336
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 28 September 2016
- Application: ANDA207441
- Marketing authorisation holder: COSETTE
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA208386
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 8 March 2017
- Application: NDA201923
- Marketing authorisation holder: ALIMERA SCIENCES INC
- Indication: Labeling
- Status: approved
FDA — authorised 17 July 2017
- Application: ANDA202849
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL/DROPS — OTIC
- Status: approved
FDA — authorised 11 April 2018
- Application: ANDA210736
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: FLAC
- Indication: OIL/DROPS — OTIC
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA210539
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 5 November 2018
- Application: ANDA210747
- Marketing authorisation holder: COSETTE
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 December 2018
- Application: ANDA211815
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: FLUOCINONIDE ACETONIDE
- Indication: OIL/DROPS — OTIC
- Status: approved
FDA — authorised 5 February 2021
- Application: ANDA213264
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL/DROPS — OTIC
- Status: approved
FDA — authorised 2 April 2021
- Application: ANDA212761
- Marketing authorisation holder: QUAGEN
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA — authorised 2 April 2021
- Application: ANDA212760
- Marketing authorisation holder: QUAGEN
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OIL — TOPICAL
- Status: approved
FDA
- Application: ANDA088312
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA087158
- Marketing authorisation holder: ALLERGAN HERBERT
- Local brand name: FLUONID
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA
- Application: ANDA087157
- Marketing authorisation holder: ALLERGAN HERBERT
- Local brand name: FLUONID
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA088360
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: FLUOCET
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA088361
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA087156
- Marketing authorisation holder: ALLERGAN HERBERT
- Local brand name: FLUONID
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Marketing authorisation holder: RISING
- Status: approved
FDA
- Application: ANDA088046
- Marketing authorisation holder: PHARMADERM
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA088047
- Marketing authorisation holder: ALLIED
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA088048
- Marketing authorisation holder: ALLIED
- Local brand name: FLUOCINOLONE ACETONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
Fluocinolone Acetonide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Fluocinolone Acetonide approved in United States?
Yes. FDA authorised it on 15 February 1963; FDA authorised it on 11 June 1963; FDA authorised it on 27 May 1964.
Who is the marketing authorisation holder for Fluocinolone Acetonide in United States?
EUROFARMA holds the US marketing authorisation.